Y-mAbs Announces NMPA Submission of BLA for DANYELZA (naxitamab-gqgk) in China
NEW YORK, July 06, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (“Y-mAbs”, NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”) has submitted the Biologics License Application (“BLA”) for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the National Medical Products Administration (“NMPA”) of China.
Zhao Hong, the Chief Executive Officer and president of SciClone Pharmaceuticals, said: “Thanks to NMPA’s reform to accelerate the launch of global innovative drugs in China, we are excited that within just seven months after FDA’s approval of DANYELZA, we have been able to submit our BLA to the NMPA in China. We are very pleased about the progress we are making and look forward to providing this innovative therapy to pediatric patients in China as quickly as possible.”
“We are pleased with the development capabilities of SciClone Pharmaceuticals resulting in accelerated timelines for submitting the DANYELZA BLA in China. We believe this BLA submission marks another important milestone in our aim to make DANYELZA globally available and address a clear unmet medical need for families in China. We look forward to working closely with SciClone Pharmaceuticals on the production and logistic planning of DANYELZA, if approved by the NMPA, to make sure it will be in the market soon,” commented Thomas Gad, founder, Chairman and President at Y-mAbs.
Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.
About DANYELZA (naxitamab-gqgk)
DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.